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Completed

NCT Number: NCT05122208

Famotidine in Covid-19 Intensive Care Unit

The COVID-19 disease, caused by SARS-CoV-2 virus, started in December 2019 and created a pandemic with high mortality and morbidity. Since a fully proven treatment has not been developed, the efficacy of currently available treatments is being investigated. Famotidine, an H2Receptor blocker, is one of the drug treatments being investigated. In this study, we aimed to investigate the effect of Famotidine treatment on the clinic and mortality of Covid-19 patients treated in the intensive care unit.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medeniyet University

Istanbul, 34730, Turkey (Türkiye)

About this study

The computer and written records of the patients followed in the Covid-19 Intensive Care Units of a research hospital during the pandemic process will be examined. Patients over the age of 18 who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR (Polymeraze Chaine Reaction) will be included in the study. Patients with immunosuppression, end-stage renal disease, liver disease, G6PD deficiency, ALT/AST >5, long QT syndrome in ECG, diagnosed with psoriasis, porphyria, pregnant, and allergic reactions to famotidine or similar drugs were excluded from the study. Patients' age, gender, comorbidities, smoking and APACHE II score will be recorded. Patients who were administered Famotidine 160 mg/day PO or nasogastric and were not given this treatment since their admission to the intensive care unit will be compared. The primary outcome will be the need for invasive mechanical ventilation, intensive care mortality, and both. As a secondary outcome, serum markers indicating the severity of the disease (Leukocytes, lymphocytes, neutrophils/leukocytes, platelets, ferritin, CRP, D-Dimer, fibrinogen, procalcitonin, IL-6, troponin, creatinine, AST, ALT, P/F ratio and lactate) will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR

Exclusion criteria

  • immunosuppression
  • end-stage renal disease
  • liver disease
  • G6PD deficiency
  • long QT syndrome in ECG
  • psoriasis
  • porphyria
  • pregnant
  • allergic reactions to famotidine or similar drugs

Treatment and study plan

Famotidine Tablets

Drug

160 mg/day Famotidine

Primary outcomes

  1. Number of patients who died in intensive care

    Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

    Mortality in intensive care

  2. Number of patients who were intubated in intensive care

    Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

    Development of respiratory distress requiring intubation in the patient

Secondary outcomes

  1. Ferritin

    Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

    Ferritin in nonogram/miiliter

  2. CRP

    Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

    C-Reactive protein in miligram/liter

  3. D-Dimer

    Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

    D-Dimer in nonogram/miiliter

  4. Fibrinogen

    Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

    Fibrinogen in nonogram/miiliter

  5. Procalcitonin

    Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

    Procalcitonin in nonogram/miiliter

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

Clinical Effects of Famotidine Use in Intensive Care Covid-19 Patients

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2021
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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